A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

May 22, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and When Coadministered With Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C).

The goals of this trial are to evaluate:

  • if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood
  • if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood
  • the safety and tolerability of taking MK-7262 and enlicitide alone and together

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has Lp(a) ≥ 150 nmol/L
  • Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
  • Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization
  • Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load)
  • Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection
  • Has a history of nephrotic syndrome
  • Has severe renal insufficiency
  • Has received certain therapies in the prohibited timeframe as specified in the protocol
  • Has active or chronic hepatobiliary or hepatic disease
  • Has poorly controlled Type 1 or Type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Drug: Placebo for MK-7262
Oral Coated Tablet
Drug: Placebo for enlicitide
Oral Coated Tablet
Active Comparator: enlicitide monotherapy
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Drug: Placebo for MK-7262
Oral Coated Tablet
Drug: Enlicitide
Oral Coated Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate
Experimental: MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Drug: Placebo for enlicitide
Oral Coated Tablet
Drug: MK-7262
Oral Coated Tablet
Other Names:
  • HRS-5346
Experimental: MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
Drug: Enlicitide
Oral Coated Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate
Drug: MK-7262
Oral Coated Tablet
Other Names:
  • HRS-5346

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).
Baseline and Week 8
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.
Baseline and Week 8
Number of Participants who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 20 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 20 Weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 12 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with enlicitide monotherapy versus placebo.
Baseline and Week 8
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 monotherapy versus placebo.
Baseline and Week 8
Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in Lp(a) between participants treated with MK-7262 + enlicitide versus MK-7262 monotherapy.
Baseline and Week 8
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 + enlicitide versus enlicitide monotherapy.
Baseline and Week 8
Percentage of Participants with Lp(a) <125 nmol/L at Week 8
Time Frame: Week 8
Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <125 nmol/L. The percentage of participants with Lp(a) <125 nmol/L at week 8 will be reported.
Week 8
Percentage of Participants with Lp(a) <75 nmol/L at Week 8
Time Frame: Week 8
Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <75 nmol/L. The percentage of participants with Lp(a) <75 nmol/L at week 8 will be reported.
Week 8
Percent Change from Baseline in Lp(a) at Week 12
Time Frame: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a).
Baseline and Week 12
Percent Change from Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 7, 2026

Primary Completion (Estimated)

October 12, 2027

Study Completion (Estimated)

October 12, 2027

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7262-004
  • MK-7262-004 (Other Identifier: MSD)
  • U1111-1333-1832 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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